Trilucent Breast Implants Should Be Explanted - UK Medical Devices Agency
This article was originally published in The Gray Sheet
Executive Summary
Mutagenicity studies conducted by Collagen Aesthetics' LipoMatrix unit on the safety of Trilucent breast implants containing a soybean oil filler material failed to take into account the absence of aged characterized oil and the use of extracts, according to an advisory group to the UK's Medical Devices Agency (MDA).
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Trilucent breast implants
Product liability suit filed Aug. 10 in California federal court related to development, manufacture or sale of the "potentially dangerous" soy-based breast implants names Inamed, AEI (formerly Collagen Aesthetics), Cohesion Technologies, TUV, LipoMatrix, and Washington University, St. Louis as defendants. Filed by Miami attorney Jeffrey Herman of the law firm Herman & Mermelstein, the suit follows a June advisory issued by Britain's Medical Devices Agency after reports of rupture and toxicity were linked to the implants (1"The Gray Sheet" June 12, p. 12). Roughly 9,000 procedures were performed in Europe between 1995-1999; about 2,000 woman have had their implants removed